BMS-986497 for Leukemia and Myelodysplastic Syndrome

Recruiting at 19 trial locations

Overseen By First line of the email MUST contain NCT # and Site #.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Bristol-Myers Squibb

Disqualifiers: Acute promyelocytic leukemia, CNS leukemia, active solid tumor, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

The purpose of this study is to assess the safety, tolerability, drug levels, drug efficacy and determine the recommended dose of BMS-986497 as a monotherapy, in double combination with Azacitidine and in triple combination with Azacitidine and Venetoclax in participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).

Research Team

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Eligibility Criteria

This trial is for individuals with relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Participants should have these conditions confirmed and not be responding to standard treatments. Specific eligibility criteria are not provided, but typically include factors like age, health status, and prior treatment history.

Inclusion Criteria

I have AML or MDS that has come back or didn't respond to treatment.

My cancer cells show CD33.

I have tried other treatments that didn't work for me.

Exclusion Criteria

I have been diagnosed with Acute Promyelocytic Leukemia.

Pregnant or breastfeeding

Other protocol-defined inclusion/exclusion criteria apply.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of BMS-986497 to assess safety and determine the recommended dose

8-12 weeks

Dose Expansion

Participants receive the recommended dose of BMS-986497 to further assess safety and efficacy

12-16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• BMS-986497

Trial Overview The study is testing BMS-986497's safety, tolerability, how the body processes it, its effectiveness in treating AML/MDS, and to establish the appropriate dosage. It's likely that participants will receive varying doses of BMS-986497 to find out which one works best with manageable side effects.

Participant Groups

Group I: Part 2, Cohort B: Dose Expansion BMS-986497 (Triple Combination Therapy) Experimental Treatment 3 Interventions

Group II: Part 2, Cohort A: Dose Expansion BMS-986497 (Combination Therapy) Experimental Treatment 2 Interventions

Group III: Part 1: Dose Escalation BMS-986497 (Monotherapy) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania